Current Report Filing (8-k)
November 03 2022 - 7:34AM
Edgar (US Regulatory)
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2022-11-03
2022-11-03
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): November 3, 2022
ABEONA
THERAPEUTICS INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-15771 |
|
83-0221517 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
1330
Avenue of the Americas, 33rd Floor,
New
York, NY 10019
(Address
of principal executive offices) (Zip Code)
(646)
813-4712
(Registrant’s telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 par value |
|
ABEO |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 |
Regulation
FD Disclosure. |
Abeona
Therapeutics Inc. (the “Company”) hereby furnishes the Phase 3 VIITAL Study Topline Results Presentation the Company expects
to present to analysts and investors on or after November 3, 2022. The Company expects to use the Phase 3 VIITAL Study Topline Results
Presentation, in whole or in part, and possibly with modifications, from time to time in connection with presentations to potential investors,
strategic partners, industry analysts and others. The Phase 3 VIITAL Study Topline Results Presentation is attached hereto as Exhibit
99.1 and is incorporated by reference herein, and is available under the “Company Information” tab in the “Investors & Media” section of the Company’s website, located at www.abeonatherapeutics.com.
By furnishing the information
contained in this Current Report on Form 8-K, the Company makes no admission as to the materiality of any information in this report
that is required to be disclosed solely by reason of Regulation FD.
The
information contained in the Phase 3 VIITAL Study Topline Results Presentation is summary information that is intended to be
considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public
announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or
obligation to publicly update or revise the information contained in this report, except as may be required by the federal
securities laws, although it may do so from time to time as its management believes is warranted. Any such updating may be made
through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The
information furnished pursuant to Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be considered
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into future filings by the Company under
the Securities Act of 1933, as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filings that
such information is to be considered “filed” or incorporated by reference therein.
On
November 3, 2022, the Company issued a press release entitled “Abeona Therapeutics Announces Positive Topline Results with Both
Co-Primary Endpoints Met in Pivotal Phase 3 VIITAL™ Study of EB-101.” The full text of the press release is included as Exhibit
99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item
9.01 |
Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
Abeona
Therapeutics Inc. |
|
(Registrant) |
|
|
|
|
By: |
/s/
Joseph Vazzano |
|
Name: |
Joseph
Vazzano |
|
Title: |
Chief
Financial Officer |
Date:
November 3, 2022
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